NDC 43913-403 G-bronco-d

NDC Product Code 43913-403

NDC 43913-403-16

Package Description: 474 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

G-bronco-d with NDC 43913-403 is a product labeled by Mclaren Medical Inc. The generic name of G-bronco-d is . The product's dosage form is and is administered via form.

Labeler Name: Mclaren Medical Inc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • WATER (UNII: 059QF0KO0R)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITOL (UNII: 506T60A25R)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mclaren Medical Inc
Labeler Code: 43913
Start Marketing Date: 07-01-2012 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2017 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Dextromethorphan

Dextromethorphan is pronounced as (dex troe meth or' fan)

Why is dextromethorphan medication prescribed?
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat th...
[Read More]
Guaifenesin

Guaifenesin is pronounced as (gwye fen' e sin)
Why is guaifenesin medication prescribed?
Guaifenesin is used to relieve chest congestion. Guaifenesin may help control symptoms but does not treat the cause of symptoms or speed recovery. Guaifenesin is in a cla...
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Phenylephrine

Phenylephrine is pronounced as (fen il ef' rin)
Why is phenylephrine medication prescribed?
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will ...
[Read More]

* Please review the disclaimer below.

G-bronco-d Product Label Images

G-bronco-d Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Drug Facts

Otc - Purpose

Active Ingredients (in each 5mL)PurposeGuaifenesin 200 mgExpectorantDextromethorphan 10 mgAntitussivePhenylephrine 5 mgNasal Decongestant

Uses

  • Temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common coldFor the temporary relief of nasal congestion due to the common coldHelps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not exceed recommended dosage.

Otc - Stop Use

If nervousness, dizziness, or sleeplessness occurs, discontinue use and consult a doctor.

Otc - Ask Doctor

If symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.

A persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.

Otc - Do Not Use

Do not take this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Do not take this product for persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.Do not use if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use. In case of accidental overdose, seek professional assistance or contact a poison control center immediately.

Otc - Keep Out Of Reach Of Children

Keep this and all drugs out of the reach of children.

Directions

  • Do not take more than 6 doses in any 24-hour period.Adults and children 12 years of age and over2 teaspoons every 4 hoursChildren 6 to under 12 years of age1 teaspoon every 4 hoursChildren 2 to under 6 years of age½ teaspoon every 4 hoursChildren under 2 years of ageConsult a physician

Inactive Ingredients

Citric acid, flavor, hydroxymethylcellulose, methylparaben, polysorbate, propylene glycol, propylparaben, purified water, sorbitan monooleate, sorbitol and sucralose.

Other Information

Store at 20°-25°C (68°-77°F)Do not refrigerate

* Please review the disclaimer below.